GZ-130P
Report
- Report Number
- 8030229-2023-03769
- Event Type
- Malfunction
- Date Received
- September 22, 2023
- Date of Event
- August 24, 2023
- Report Date
- August 12, 2024
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921117415
- PMA / PMN Number
- K153707
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER (TELE) IS CONSTANTLY REBOOTING. THEY HAVE ALREADY TRIED TO TROUBLESHOOTING THE UNIT AND WAS UNABLE TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
UDI RELATED DATA QUALITY UPDATES ONLY: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM GZ-130PA TO GZ-130P. D2B PRODUCT CODE: CORRECTED THE PRODUCT CODE FROM DRT TO MHX. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM GZ-130PA TO GZ-130P. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM GZ-130PA TO GZ-130P. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A, PER THE FDA REQUEST.
DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER (TELE) IS CONSTANTLY REBOOTING. THEY HAVE ALREADY TRIED TO TROUBLESHOOTING THE UNIT AND WAS UNABLE TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE COMPLAINT UNIT WAS RETURNED AND WAS EVALUATED. THE DEVICE WAS NOT TURNING ON. NK REPAIR CENTER WAS UNABLE TO OBSERVE THE CONSTANT REBOOT ISSUE DUE TO THE DEVICE NOT TURNING ON. THE BATTERIES OF THE DEVICE WERE REPLACED BUT THE DEVICE WOULD STILL NOT TURN ON. NK REPAIR CENTER NOTED THAT THE BATTERY PORT HAS "HEAVY CORROSION". THE CORROSION AT THE BATTERY PORT IS LIKELY CAUSING THE CONSTANT REBOOT AND POWER ISSUES ON THE DEVICE. THE CORROSION ON THE BATTERY PORT IS LIKELY CAUSED BY FLUID INTRUSION. RESIDUAL MOISTURE ON THE DEVICE COULD HAVE DRIED UP AND HAD CAUSED THE CORROSION OF THE BATTERY PORT. PER OPERATOR'S MANUAL OF THE DEVICE, THE DEVICE IS WATERPROOF BUT THE BATTERY CASE, ELECTRODE LEAD, AND SPO2 PROBE ARE NOT WATERPROOF.
THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER (TELE) IS CONSTANTLY REBOOTING. THEY HAVE ALREADY TRIED TO TROUBLESHOOTING THE UNIT AND WAS UNABLE TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER (TELE) IS CONSTANTLY REBOOTING. THEY HAVE ALREADY TRIED TO TROUBLESHOOTING THE UNIT AND WAS UNABLE TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER (TELE) IS CONSTANTLY REBOOTING. THEY HAVE ALREADY TRIED TO TROUBLESHOOTING THE UNIT AND WAS UNABLE TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1295304 | GZ-130P | TRANSMITTER | MHX | NIHON KOHDEN CORPORATION | GZ-130P | NA | 04931921117415 |
| 2333890 | GZ-130P | TRANSMITTER | MHX | NIHON KOHDEN CORPORATION | GZ-130P | NA | 04931921117415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CENTRAL NURSE'S STATION.| CENTRAL NURSE'S STATION.| CENTRAL NURSE'S STATION. |